FDA.reportPublic FDA data

Ombra®

Primary DI
00604351637016
Brand
Ombra®
Company
Monaghan Medical Corporation
Model
Compressor Kit, DME, Adult
Published
2018-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTICompressor, Air, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTICompressor, Air, PortableAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50604351637011PackageGS11In Commercial Distribution
00604351637016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5060435163701150604351637011
00604351637016006043516370166043516370160604351637016

GMDN Terms#

Term, Definition table
TermDefinition
Medical device air compressorA mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.

Contacts#

Phone, Email table
PhoneEmail
518-561-7330customerservice@monaghanmed.com

Regulatory Flags#

DUNS number
056332380
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00604351673106MC 300 Reusable NebulizerMC3002026-05-26
00604351506121Aerochamber2go Anti-Static Valved Holding ChamberAeroChamber2go, cs/122025-05-30
00604351505124Aerobika,OPEP Aerobika, OPEP Device, Retail2024-05-16
00604351707061Nasoneb®NasoNeb Sinus Therapy System cs/62024-10-25
50604351707066Nasoneb®NasoNeb Sinus Therapy System cs/62024-10-25
50604351505129Aerobika,OPEP Aerobika, OPEP Device, Retail2024-05-16
00604351350014Nasoneb®NasoNeb Compressor2024-04-09
00604351504127Aerochamber Plus® Flow-Vu®aVHC, Intermediate Mask, cs/122024-03-01
50604351504122Aerochamber Plus® Flow-Vu®aVHC, Intermediate Mask, cs/122024-03-01
00604351501126Aerochamber Plus® Flow-Vu®aVHC, Small Mask, cs/122023-11-14
00604351502123Aerochamber Plus® Flow-Vu®aVHC, Medium Mask, cs/122023-11-14
00604351503120Aerochamber Plus® Flow-Vu®aVHC, Large Mask, cs/122023-11-14
00604351500129Aerochamber Plus® Flow-Vu®aVHC, Mouthpiece, cs/122023-11-14
50604351501121Aerochamber Plus® Flow-Vu®aVHC, Small Mask, cs/122023-11-14
50604351502128Aerochamber Plus® Flow-Vu®aVHC, Medium Mask, cs/122023-11-14
50604351503125Aerochamber Plus® Flow-Vu®aVHC, Large Mask, cs/122023-11-14
00604351886858MonaghanKit, Educational, MMC Z STAT™ aVHC886852018-10-12
00604351788015Aerochamber Plus® Flow-Vu®aVHC, Medium Mask, NFR, Single2016-10-10
00604351798014Aerochamber Plus® Flow-Vu®aVHC, Mouthpiece, NFR, Single2016-10-10
00604351808010Aerochamber Plus® Flow-Vu®aVHC, Large Mask, NFR, Single2016-10-10

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Primary DI, Brand, Company table
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00197344042817MedlineMEDLINE INDUSTRIES, INC.BTI2024-02-16
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